Background

The Food and Drug Administration is proposing to make certain changes to its regulations on prior notice for imported foods. Comments on the proposed changes are due by approximately Feb. 1, 2024.

The FDA uses prior notice information to determine which products should be inspected upon arrival in the U.S. The agency is now proposing to make the following changes to its prior notice regulations.

- add a requirement that prior notice information be submitted within 10 calendar days, and food facility registration information be submitted within 30 calendar days, from the date a notice of refusal or hold was issued (this change could reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges)

- add a requirement for people submitting prior notice for articles of food arriving by international mail to provide the name of the mail service and the mail tracking number (to enable the FDA to better coordinate with U.S. Customs and Border Protection and the U.S. Postal Service to track and inspect articles identified as a possible bioterrorism risk)

- remove the requirement that prior notice of goods arriving by international mail be submitted through the FDA’s Prior Notice Systems Interface and instead allow such notice to be submitted via PNSI or the Automated Broker Interface/Automated Commercial Environment/International Trade Data System

For more information on this proposal, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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